Methods of post-filling a spinal implant

ABSTRACT

According to some embodiments, a method for promoting spinal fusion using a spinal implant comprises providing a spinal implant, wherein the spinal implant comprises an anterior wall, a posterior wall and two lateral walls configured to extend between the anterior wall and the posterior wall. In some embodiments, the spinal implant further comprises at least one internal chamber generally positioned between the anterior wall, the posterior wall and the two lateral walls, wherein the internal chamber being is adapted to receive at least one graft and/or other fill material. In some embodiments, at least a portion of the graft and/or other fill material delivered into the internal chamber is configured to exit through the one or more of the openings of the anterior wall.

Priority Data

This application is a continuation application of U.S. application Ser.No. 15/782,712, filed Oct. 12, 2017, which is a continuation of U.S.application Ser. No. 13/725,933, filed Dec. 21, 2012, now U.S. Pat. No.9,788,973, which is a continuation of U.S. application Ser. No.13/049,693, filed Mar. 16, 2011, now U.S. Pat. No. 8,343,224, whichclaims the priority benefit under 35 U.S.C. § 119(e) of U.S. ProvisionalApplication No. 61/314,509, filed Mar. 16, 2010, and U.S. ProvisionalApplication No. 61/389,671, filed Oct. 4, 2010. The entire contents ofall of the foregoing applications are hereby incorporated by referenceherein.

BACKGROUND Field

This application generally relates to spinal fusion, and morespecifically, to spinal implants and related systems, tools and methods.

Description of the Related Art

Intervertebral discs can degenerate or otherwise become damaged overtime. In some instances, an intervertebral implant can be positionedwithin a space previously occupied by a disc. Such implants can helpmaintain a desired spacing between adjacent vertebrae and/or promotefusion between adjacent vertebrae. The use of bone graft and/or othermaterials within spinal implants can facilitate the fusion of adjacentvertebral bodies. Accordingly, a need exists for an improvedintervertebral implant, as well as related instrumentation, tools,systems and methods.

SUMMARY

According to some embodiments, a spinal implant configured for placementwithin an intervertebral space of a patient comprises an anterior wall,a posterior wall, a first lateral wall and a second lateral wall, suchthat the first and second lateral walls generally extend between theanterior wall and the posterior wall. The spinal implant additionallycomprises at least one internal chamber defined, at least in part, bythe anterior wall, the posterior wall and the first and second lateralwalls. In some embodiments, the implant comprises a top surface having aplurality of teeth configured to at least partially engage a lowersurface of a first vertebral body and/or a bottom surface comprising aplurality of teeth configured to at least partially engage an uppersurface of a second vertebral body, the second vertebral body beingadjacent to said first vertebral body. In some embodiments, the at leastone internal chamber extends at least partially from the top surface tothe bottom surface of the implant. The implant further comprises atleast one opening extending through the anterior wall, wherein such anopening is in fluid communication with the internal chamber. In someembodiments, the spinal implant additionally comprises at least oneaccess port located in the anterior wall, the first lateral wall and/orthe second lateral wall. In some embodiments, the implant is configuredto releasably secure to an insertion tool using the access port. In someembodiments, the implant is configured to span across an entire width orsubstantially an entire width of the adjacent vertebral bodies. In oneembodiment, the access port is configured to receive at least one graftmaterial delivered into the at least one internal chamber. In someembodiments, the posterior wall does not comprise any openings.

According to some embodiments, excess graft material delivered into theat least one internal chamber through the access port is configured toexit the implant through one or more openings of the anterior wall. Inone embodiment, the access port is threaded, so that a delivery toolcomprising a corresponding thread pattern can be selectively attachedand detached to the spinal implant. In some embodiments, the implantcomprises one or more recesses and/or other features configured to matewith corresponding flanges or other protruding members of an implantdelivery tool. In one embodiment, each of the first and second lateralwalls is configured to generally align with peripheral bearing areas ofthe adjacent vertebral members. In other embodiments, the teeth alongthe top and/or bottom surfaces of the implant are configured to slanttoward a lateral center of the implant. In some embodiments, the slantedteeth help retain the implant within the target intervertebral spaceafter implantation and/or help reduce the likelihood the migration ofgrafting materials out of the at least one internal chamber of theimplant along the top and bottom surfaces of the implant.

According to some embodiments, the first lateral wall and/or the secondlateral wall comprises a tapered portion to facilitate insertion of theimplant into the intervertebral space. In one embodiment, the spinalimplant further comprises a plurality of prongs that extend into theinternal chamber for retaining a graft or other member positionedtherein. In some embodiments, such prongs are configured to retain atleast one of a sponge, a porous foam and cured grafting materials withinthe at least one internal chamber of the implant. In some embodiments,the implant is configured for placement within a lumbar or thoracicportion of a patient's spine. In some embodiments, the implant isconfigured for lateral or anterior insertion into the intervertebralspace. In several embodiments, the implant comprises polyetheretherketone (PEEK) and/or any other material.

According to some embodiments, the length of each of the first andsecond lateral walls is approximately 10% to 20% of an overall length ofthe implant. In other embodiments, the length of each of the first andsecond lateral walls is less than about 10% or greater than about 20% ofan overall length of the implant. In one embodiment, the teeth along atleast one of the top and/or bottom surfaces of the implant are oriented,at least in part, in a concentric manner. In one embodiment, a radius ofcurvature of the teeth along at least one of the top and bottom surfacesof the implant increases with increasing distance from a center of theimplant. In some arrangements, the top and/or bottom surfaces of theimplant are generally planar. In other embodiments, the top and/orbottom surfaces of the implant are generally curved, fluted, roundedand/or non-planar.

According to some embodiments, the implant comprises a lordotic implant,such that a height of the first lateral wall is greater than a height ofthe second lateral wall. In some embodiments, the internal chamber doesnot comprise any interior walls or baffles. In alternative embodiments,the internal chamber comprises at least two internal sub-chambersdivided by at least one interior wall or baffle. In one embodiment, theimplant comprises at least one radio-opaque marker. In severalembodiments, the access port is generally circular. In otherembodiments, the access port is non-circular (e.g., square, otherrectangular or polygonal, oval, elliptical, irregular, etc.).

According to some embodiments, the access port comprises a minimumdiameter of approximately 6 mm. In other embodiments, the diameter orother cross-sectional dimension of the access port is greater or lessthan about 6 mm (e.g., 4 mm, 5 mm, 7 mm, 8 mm, etc.). In someembodiments, the access port is adapted to receive a fill tube, catheteror other conduit therethrough, wherein such fill tube, catheter or otherconduit is configured to selectively deliver a grafting or fill materialinto the internal chamber of the implant. In some embodiments, a ratioof a diameter of the at least one access port to a height of the firstor second lateral wall through which the at least one access port islocated is between approximately 0.4 and 0.8 (e.g., about 0.4, 0.45,0.5, 0.55, 0.6, 0.65, 0.7, 0.75, 0.8, 0.85, 0.9, etc.). In oneembodiment, a minimum ratio of a diameter of the at least one accessport to a height of the first or second lateral wall through which theat least one access port is located is approximately 0.5, 0.6, 0.7 or0.8.

According to some embodiments, the access port comprises a valve orother flow blocking device or feature to help retain grafting materialswithin the at least one internal chamber of the implant. In someembodiments, an exterior profile of the anterior wall is generallycurved. In some arrangements, an exterior profile of the posterior wallis generally planar.

According to some embodiments, a method for promoting spinal fusioncomprises providing a spinal implant (e.g., such as one of the implantsdisclosed herein or equivalents thereof) and positioning the spinalimplant between two adjacent vertebral bodies or vertebrae of a patient.The method further comprises directing at least one graft material intothe internal chamber of the spinal implant through a port of theimplant. In some embodiments, at least a portion of the graft and/orother filler material (e.g., materials in excess of the capacity of theimplant) delivered into the at least one internal chamber is configuredto exit through one or more openings of the anterior wall when asufficient amount of the at least one graft material has been deliveredinto the at least one internal chamber.

According to some embodiments, positioning the spinal implant betweentwo adjacent vertebrae comprises removably securing the spinal implantto the distal end of an insertion tool assembly, wherein the insertiontool assembly is secured to, at least in part, to the access port of thespinal implant. In some embodiments, the access port is used to bothsecure the implant to an implant delivery tool and to deliver graftingand/or other materials to the inside of the implant. In someembodiments, directing graft and/or other materials into the internalchamber comprises passing such materials through a cannulated portion ofthe insertion tool assembly. In other embodiments, directing thematerial into the internal chamber comprises passing the materialsthrough a separate conduit adapted to be removably positioned within theaccess port of the spinal implant. In one embodiment, directing thegraft and/or other materials into the internal chamber comprisesinjecting such materials through tubing using a syringe.

According to some embodiments, the tubing is routed through an internalpassage of a fill tube assembly, wherein fill tube assembly isconfigured to engage at least a portion of the spinal implant while thegraft and/or other materials are directed into the internal chamber ofthe implant. In some embodiments, at least a portion of the graftmaterial delivered into the internal chamber is configured to exitthrough an interface between the upper and/or lower surface of theimplant and the adjacent endplate surfaces of the vertebral bodies. Insome embodiments, at least a portion of the internal chamber comprises agraft material prior to positioning the spinal implant between the twoadjacent vertebrae. In some embodiments, an additional volume of a graftmaterial is delivered into the internal chamber of the implant after thespinal implant has been secured between the two adjacent vertebrae.

According to some embodiments, the method further includes preparing atleast one adjacent vertebral body surface for the delivery of the spinalimplant, wherein preparing an adjacent vertebral body surface comprisesabrading said surface using a rasping and/or other abrading orroughening tool. In some embodiments, such tools comprise one or moreroughened surfaces or features configured to abrade bone and/or othertissue. In some embodiments, the method additionally comprises placing asizing tool within a target intervertebral space prior to positioningthe spinal implant between two adjacent vertebrae of a patient in orderto determine the appropriate size of said spinal implant. In someembodiments, the sizing tool is configured to distract the adjacentvertebrae by a desired distance.

According to some embodiments, a kit includes a spinal implant (e.g.,such as any of those disclosed herein or equivalents thereof), animplant delivery tool configured to removably secure to the spinalimplant and a graft material delivery system configured to selectivelydeliver at least one graft and/or other filler material into an interior(e.g., internal chamber) of the spinal implant. In some arrangements,the graft material delivery system comprises a syringe, a sizing tooland a conduit configured to pass through the at least one access port ofthe spinal implant.

According to some embodiments, a method for promoting spinal fusionusing a spinal implant comprises providing a spinal implant, wherein thespinal implant comprises an anterior wall, a posterior wall and twolateral walls configured to extend between the anterior wall and theposterior wall. In some embodiments, the spinal implant furthercomprises at least one internal chamber generally positioned between theanterior wall, the posterior wall and the two lateral walls, wherein theinternal chamber being is adapted to receive at least one graft and/orother fill material. In some arrangements, the anterior wall of thespinal implant comprises at least one opening or hole that places theinternal chamber in fluid communication with an exterior area or portionof the spinal implant. In one embodiment, at least one of the twolateral walls comprises an access port. The method additionally includespositioning the spinal implant between two adjacent vertebrae of apatient and directing at least one graft and/or other fill material intothe internal chamber of the spinal implant through the access port. Insome embodiments, at least a portion of the graft and/or other fillmaterial delivered into the internal chamber is configured to exitthrough the one or more of the openings of the anterior wall.

In some embodiments, positioning the spinal implant between two adjacentvertebrae comprises removably securing the spinal implant to the distalend of an insertion tool assembly, wherein the insertion tool assemblyis secured to, at least in part, to the access port of the spinalimplant. In one embodiment, directing the graft material into theinternal chamber comprises passing the graft material through acannulated portion of the insertion tool assembly. In some embodiments,directing the graft material into the internal chamber comprisesinjecting one or more graft materials through flexible tubing using asyringe. In some embodiments, the flexible tubing is routed through aninternal passage of a fill tube assembly, wherein the fill tube assemblyis configured to engage at least a portion of the spinal implant whilethe graft material is being directed into the internal chamber. In somearrangements, at least a portion of the graft and/or other fill materialdelivered into the internal chamber is configured to exit through aninterface between the upper surface and/or lower surface of the spinalimplant and an adjacent endplate surface of a vertebral body. In oneembodiment, at least a portion of the internal chamber comprises a graftmaterial prior to positioning the spinal implant between the twoadjacent vertebrae. In some embodiments, such a pre-loaded graftmaterial or item comprises a graft, an absorbent sponge or other memberand or the like.

According to some embodiments, an implant configured for placementwithin an intervertebral space of a patient comprises an anterior wall,a posterior wall, a first lateral wall and a second lateral wall,wherein the first and second lateral walls are configured to extendbetween the anterior wall and the posterior wall. The implant furtherincludes a top surface having a plurality of teeth adapted to at leastpartially engage a lower surface of a first vertebral body and a bottomsurface having a plurality of teeth adapted to at least partially engagean upper surface of a second vertebral body, wherein the secondvertebral body is adjacent to the first vertebral body. The implantfurther comprises one or more internal chambers positioned between theanterior wall, the posterior wall, the first lateral wall and the secondlateral wall, wherein the internal chamber at least partially extendsfrom the top surface to the bottom surface of the implant.

In some embodiments, the implant additionally includes at least oneopening extending through the anterior wall, wherein the opening is influid communication with the internal chamber. In one embodiment, theimplant further comprises at least one access port located in theanterior wall, the first lateral wall and/or the second lateral wall,wherein the implant is configured to releasably secure to an insertiontool using the access port. In some embodiments, the access port isconfigured to receive a graft material that is delivered into theinternal chamber after the implant has been secured within theintervertebral space. In one embodiment, the posterior wall does notcomprise any openings. In some arrangements, the graft materialdelivered into the internal chamber is configured to exit the implantthrough at least one opening of the anterior wall.

According to some embodiments, the implant comprises polyetheretherketone (PEEK). In several arrangements, the length of each of thefirst and second lateral walls is approximately 10-20% of the overalllength of the implant. In some embodiments, each of the first and secondlateral walls is configured to generally align with the peripheralbearing areas of the adjacent vertebral members. In some embodiments,the plurality of teeth situated along the top and/or bottom surfaces ofthe implant are configured to slant to toward a lateral center of theimplant. In one embodiment, the first lateral wall and/or the secondlateral wall comprises a tapered portion to facilitate insertion of theimplant into the intervertebral space. In some arrangements, the implantis configured for lateral, anterior or posterior insertion into thetargeted intervertebral space. In some embodiments, the implant isconfigured for placement within a lumbar or thoracic portion of apatient's spine. In one embodiment, the implant additional comprises aplurality of prongs extending into the interior chamber for retaining agraft or other member positioned therein.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features, aspects and advantages of the presentapplication are described with reference to drawings of certainembodiments, which are intended to illustrate, but not to limit, thepresent disclosure. It is to be understood that these drawings are forthe purpose of illustrating concepts of the present disclosure and maynot be to scale.

FIG. 1A illustrates a front perspective view of a spinal implantaccording to one embodiment;

FIG. 1B illustrates a rear perspective view of the implant of FIG. 1A;

FIG. 2 illustrates a top view of the implant of FIG. 1A;

FIG. 3A illustrates a side view of the implant of FIG. 1A;

FIGS. 3B and 3C illustrate detailed side views of the implant of FIG.1A;

FIGS. 4 and 5 illustrate different side views of the implant of FIG. 1A;

FIG. 6A illustrates perspective views of an implant and an insertiontool configured to engage the implant according to one embodiment;

FIG. 6B illustrates a partial top view of a spinal implant according toone embodiment;

FIG. 6C illustrates a perspective view of a spinal implant according toone embodiment;

FIG. 6D illustrates a top view of a spinal implant according to oneembodiment;

FIG. 7A illustrates an anterior side view of an implant within atargeted intervertebral space and secured to an insertion tool assembly,according to one embodiment;

FIG. 7B illustrates lateral side view of the implant of FIG. 7A;

FIG. 8 illustrates two embodiments of sizing and distraction tools;

FIG. 9 illustrates one embodiment of a rasping or abrading tool for useas a preparatory tool in advance of implantation of a spinal implant;

FIGS. 10A and 10B illustrate perspective views of another embodiment ofa rasping or abrading tool for preparing an intervertebral space;

FIG. 11 illustrates a perspective view of an insertion tool assemblyattached to a spinal implant, according to one embodiment;

FIG. 12A illustrates an exploded perspective view of the insertion toolassembly and implant of FIG. 11;

FIG. 12B illustrates a partial cross-sectional view of an insertion toolassembly secured to an implant, according to one embodiment;

FIG. 13 illustrates a perspective view of various components of a graftfill kit, according to one embodiment;

FIG. 14 illustrates an anterior side view of a fill tool assemblyengaged with a spinal implant positioned within a targetedintervertebral space, according to one embodiment;

FIG. 15 illustrates a syringe assembly configured for post-filling aspinal implant with graft and/or other fill materials, according to oneembodiment;

FIGS. 16A-16C illustrate various view of time-sequential steps relatedto positioning a syringe assembly within a fill tool assembly, accordingto one embodiment;

FIGS. 17A and 17B illustrates different side views of excess graftand/or other fill material that has exited the interior chamber of aspinal implant, according to one embodiment;

FIG. 18 illustrates a partial cross-sectional view of an insertion toolassembly having a cannulated threaded rod and secured to an implant,according to one embodiment;

FIGS. 19 and 20 illustrate different top perspective view of a spinalimplant according to one embodiment; and

FIG. 21 illustrates a cross-sectional view of the implant of FIGS. 19and 20.

DETAILED DESCRIPTION

A variety of embodiments and examples described herein illustratevarious configurations that may be employed to achieve desiredimprovements. The particular embodiments and examples are onlyillustrative and not intended in any way to restrict the general natureof the inventions presented and the various aspects and features of andrelating to these inventions.

Spinal Implant

FIG. 1 illustrates one embodiment of a spinal implant 10 configured forplacement between adjacent vertebrae of a patient. According to certainarrangements, the implant 10 is sized, shaped and otherwise adapted forplacement with an intervertebral space along the lumbar region of spine.Alternatively, however, the implants and/or the methods disclosed hereincan be modified for placement in any other portion of the spine, suchas, for example, the thoracic or cervical region. In any of theembodiments disclosed herein, the implant can be inserted into a targetintervertebral space using a lateral delivery approach (e.g., XLIF orTLIF), an anterior approach (e.g., ALIF), a posterior approach (e.g.,PLIF) and/or any other approach or technique.

With continued reference to FIG. 1, the implant 10 can include agenerally rectangular shape. However, in alternative configurations, theimplant 10 includes another shape, as desired or required by aparticular application or use. For example, one or more of the implant'ssurfaces or sides can be more or less tapered and/or rounded (e.g.,curved, convex, etc.). Further, the implant can comprise a completelydifferent overall shape (e.g., as viewed from the top, bottom, one ormore sides, etc.), such as, for example, round, oval, elliptical, otherpolygonal, irregular and/or the like.

According to some embodiments, the top surface 12 and/or the bottomsurface 16 of the implant 10 comprise one or more teeth 40, protrudingmembers and/or other features that are sized, shaped and otherwiseconfigured to contact and engage adjacent surfaces of the vertebralendplates once the implant has been positioned within the intervertebralspace. In one embodiment, only the top surface 12 comprises teeth orsimilar engagement features. In another embodiment, only the bottomsurface 16 comprises teeth or similar engagement features. However, insome embodiments, both the top and the bottom surfaces 12, 16 compriseteeth or similar engagement features.

The teeth 40 or other engagement members or features can be distributedeither completely or partially along the top surface 12 and/or bottomsurface 16 of the implant 10. For example, the teeth or other engagementfeatures 40 can cover the entire or substantially the entire top and/orbottom surfaces of the implant. In other arrangements, the teeth 40 arelocated along only selected portions of the top and/or bottom surfaces,as desired or required. As illustrated in FIGS. 1 and 2, the teeth 40can extend, at least partially, from the anterior end 32 to theposterior end 36 of the implant. In some embodiments, at least some ofthe teeth 40 are generally parallel to each other. However, in otherarrangements, at least some of the teeth or similar engagement features40 of an implant intersect with one another or are otherwisenon-parallel relative to each other.

With continued reference to FIGS. 1 and 2, the teeth or other engagementfeatures 40 can be symmetrically disposed along the top surface 12and/or bottom surface 16 of the implant 10. Alternatively, however, thetooth pattern along the top and/or bottom surfaces of the implant can beasymmetrical in one or more directions. In the illustrated embodiment,the teeth 40 are generally straight along the middle portion of theimplant 10 and generally curved (e.g., circular, oval, etc.) along eachof the lateral ends 22, 26 of the implant 10. Thus, the radius ofcurvature of the teeth 40 along the lateral ends 22, 26 of the implantis greater than the curvature of the teeth along the middle, center orinterior portion of the implant. In some arrangements, the radius ofcurvature of the rows of teeth 40 or other engagement features canincrease with increasing distance from the center of the implant 10.

The teeth or other engagement features 40 along the top surface 12and/or the bottom surface 16 of the implant 10 can be bi-directional orunidirectional, as desired or required. Such teeth or other engagementfeatures 40 can help ensure that the implant 10 does not migrate orotherwise undesirably move after implantation within a targetintervertebral space. In addition, as discussed in greater detailherein, the teeth 40 can assist in maintaining graft and/or other fillmaterials within or near the implant 10 (e.g., within an internalchamber of the implant, between the endplates of adjacent vertebralmembers, etc.), thereby improving and/or facilitating spinal fusion. Thetype, quantity, shape (e.g., curvature along the top and/or bottomsurfaces of the implant, the cross-sectional shape of the teeth, etc.),size (height, length, etc.), orientation, spacing and/or other detailsof the teeth or other engagement features 40 can vary, as desired orrequired.

With reference to the top view of FIG. 2, the implant 10 can include aleft lateral side L and a right lateral side S. According to someembodiments, the teeth 40 along the top and/or bottom surfaces 12, 16 ofthe implant 10 are unidirectional. For example, the teeth 40 along theleft side L of the implant are generally curved, sloped, slanted orotherwise pointed in a first direction, whereas the teeth 40 along theright side R of the implant are generally curved, sloped, slanted orotherwise pointed in a second direction, which in some arrangements, isgenerally opposite of the first direction.

Further, as illustrated in the side view of FIG. 3A, in someembodiments, the teeth 40′, 40″ along the upper and/or lower surfaces12, 16 of the implant 10 are sloped or slanted toward the horizontalcenter of the implant. As noted above, such a configuration can helpensure that the implant 10 engages adjacent portions of a patient'sspine (e.g., vertebral endplate surfaces) and does not inadvertentlymigrate or otherwise move after implantation. Further, such embodimentscan help ensure that the likelihood that grafting agents and/or otherfill materials delivered into the interior chambers of the implant 10undesirably escape from within or near the implant (e.g., between theupper and/or lower surfaces 12, 16 and the adjacent endplate surfaces ofthe patient's vertebrae) is advantageously reduced or minimized. Forexample, with such a tooth orientation, the implant 10 needs to migrateor otherwise shift against the tooth grain (e.g., in one or moredirections) in order to move laterally away from the targetintervertebral space following implantation. In addition, according tosome embodiments, the inwardly oriented shape of the teeth 40 makes itmore difficult for grafting and/or other filler materials to flow orotherwise move at or near the implant-endplate interface.

As illustrated in FIG. 3A, the implant 10 can include generally planartop and/or bottom surfaces 12, 16, at least partially along its lengthand/or width. In other embodiments, however, the top surface 12 and/orthe bottom surface 16 of the implant 10 comprises one or more portionsthat are non-planar. Such non-planar areas or portions can extend onlypartially along the length and/or width of the implant. In otherembodiments, the entire top and/or bottom surface of the implant can begenerally non-planar.

For example, the top and/or bottom surfaces can be generally concave,rounded or otherwise curved (e.g., in the vertical direction so that thethickness of the implant varies along one or more regions of theimplant). Such configurations can provide for a tighter fit between theimplant 10 and the adjacent endplates or other surfaces or portions ofthe vertebral members. In some arrangements, such configurations canhelp improve or enhance the spinal fusion process. In yet otherarrangements, the implants can be generally planar but non-horizontal(e.g., from anterior to posterior ends). For instance, as discussed ingreater detail herein, “lordotic” implant designs can include agenerally higher anterior wall relative to the posterior wall.

In some embodiments, one or both lateral ends of an implant can betapered. A tapered lateral end 22, as illustrated in FIG. 3A, canfacilitate insertion of the device 10 within the target intervertebralspace during an implantation procedure. In the depicted arrangement, theleading end 97 along the right lateral end 22 of the implant 10 includesboth a vertical taper and a rounded profile when viewed from the top. Insome embodiments, as discussed in greater detail below, at least aportion of such a “bullet” or tapered leading lateral end of the devicecan be configured to extend outside the intervertebral space into whichthe implant is implanted. According to some embodiments, one or bothlateral ends of the implant comprise a rounded or curved contour. Such arounded or curved contour or profile can be included in the verticaldirection, in the horizontal direction or in both the vertical andhorizontal directions, as desired or required.

In addition, as best illustrated in FIG. 2, the exterior surface of theimplant's posterior side 36 can be generally flat or planar when viewedfrom the top. Such a design can help ensure that a proper clearance isprovided between the posterior end of the implant 10 and sensitiveportions of the patient's spine (e.g., nerve roots, spinal cord, etc.).Further, the exterior surface of the implant's anterior side 32 caninclude a rounded or other non-planar shape. In some embodiments, such arounded or other non-planar shape is relatively gradual or slight.Likewise, as shown, the exterior of the implant's lateral sides 22, 26can be either generally planar (e.g., flat) or rounded, as desired orrequired. In other embodiments, the exterior shape of the implant'ssides can be different than illustrated and discussed herein.

In order to help perform an implantation procedure and to facilitate thedelivery of an implant to a targeted location within a patient's spine,the implant 10 can include one or more insertion tool receiving ports50, slots and/or other features. For example, in the embodimentillustrated in, inter alia, FIGS. 1A, 1B, 2 and 3B, a single port 50 ispositioned along one of the lateral ends 26 of the implant 10. However,in other configurations, the port 50 can be positioned along any otherportion of the device. The location of the port 50 can depend, at leastin part, on the desired method by which the implant 10 will be insertedinto the patient's spine (e.g., laterally, anteriorly, posteriorly,etc.). For example, in the illustrated arrangement, the port 50 ispositioned along a lateral end 26, primarily because the implant 10 isdesigned to be inserted into the target intervertebral space laterally.Therefore, in other configurations, an insertion tool receiving port 50can be included along the anterior side 32, posterior side 36 and/or anyother portion of the implant.

According to some embodiments, the insertion tool receiving port 50 isconfigured to releasably engage a corresponding insertion tool using athreaded connection. For instance, the port 50 can include internalthreads that are sized, shaped and otherwise adapted to match externalthreads of an insertion tool 300 (FIG. 6A). In other arrangements,however, other types of connection features or devices are used toreleasably secure an insertion tool to the implant, such as for example,a press-fit or friction fit connection, a snap-fit connection, a tabbedconnection, any other standard or non-standard coupling and/or the like.In some embodiments, as discussed in greater detail herein, the port 50also serves as an inlet into the implant's interior chambers throughwhich grafting and/or other fill materials can be selectively deliveredwithin the implant. Thus, is such embodiments, a single port 50 is usedboth an implant delivery mechanism and a graft material passage. In someembodiments, the port 50 comprises one or more valves (e.g., checkvalve, other one-way valve, etc.), other flow-regulating devices orfeatures and/or one or more other sealing members to help prevent orreduce the likelihood of the inadvertent loss of grafting and/or otherfill materials from within the interior of an implant through such aport 50.

The port 50 can be threaded or non-threaded, as desired or required. Insome embodiments, the port comprises one or more other engagement orother features, such as for example, alignment slots, tabs, teeth, otherprotruding members and/or the like. Such features can extend inwardly(e.g., in the direction of the port's opening) from the wall or othersurface defining the port 50. According to some embodiments, the shape(e.g., cross-sectional shape) of the port is generally circular.However, the port can include one or more other shapes, such as, forexample, oval, elliptical, square, rectangular, other polygonal,irregular and/or the like.

According to some embodiments, the threaded port 50 along a lateral end26 of the implant is configured to pass at least partially through theimplant's lateral wall 98. For example, in one embodiment, the port 50passes through the entire lateral wall 98 and extends into one or moreinternal chambers 70, cavities or other openings of the implantabledevice 10. According to some embodiments, the port 50 is sized to permita catheter, syringe, tubing, other tube, conduit and/or other deliverydevice to be passed therethrough. Such a catheter or other delivery tubeor device can be sized and configured to allow grafting and/or othermaterials to be selectively injected or otherwise administered into oneor more chambers of the implant. In one embodiment, the port is sized topermit a catheter or other tube of size French 12 or French 15 (e.g.,per the standard French gauge scale) to be passed therethrough. Thus, insuch arrangements, the port 50 can include a minimum inside diameter ofabout 4 mm or about 5 mm. In other embodiments, however, the port 50 canbe sized, shaped and otherwise configured to permit the passage oflarger catheters, tubes or other conduits therethrough. For instance, insome embodiments, an implant is configured to permit a catheter, tube orother conduit having an outer diameter as large as about 5 mm through 8mm (e.g., approximately 5 mm, 5.5 mm, 6 mm, 6.5 mm, 7 mm, 7.5 mm, 8 mm,sizes between the foregoing, etc.) to pass through its port 50. In otherembodiments, the port is sized and shaped to allow conduits having anouter diameter larger than 8 mm (e.g., approximately 8 mm, 8.5 mm, 9 mm,larger than about 9 mm, etc.) to pass therethrough.

In some embodiments, the threaded port 50 or access hole comprises anM6x 1.0 configuration. However, as noted above, the port can comprise anominal diameter that is greater than or less than about 6 mm, such as,for example, approximately 4 mm, 5 mm, 7 mm, 8 mm, 9 mm, 10 mm, greaterthan 10 mm, sizes between the foregoing values, etc.). Further, inembodiments that comprise a threaded port, the thread along the insideof the port can differ from that in an M6x 1.0 configuration, as desiredor required. For example, the thread type, pattern, height and/or othercharacteristics of the thread can vary.

According to some embodiments, the spinal implants disclosed herein orequivalents thereof comprise a generally closed structure along theirsides. For example, in some arrangements, the only openings along theouter sidewalls (e.g., lateral, posterior, anterior) of an implant areone or more ports 50 (e.g., used to engage the implant with a deliverytool and/or used to pass a graft delivery tube to the interior of theimplant) and/or one or more openings that permit excess graftingmaterials to exit an interior chamber or other cavity of the implant(e.g., openings 60 along the anterior side wall of the implant, asillustrated in FIG. 3A).

According to some embodiments, the port 50 or other openings through awall of the implant is configured to be as large as possible for a givenimplant. This can permit a larger device (e.g., catheter, syringe,tubing, other conduit or device, etc.) to be positioned therein. Forexample, as discussed in greater detail herein, the port 50 can beadvantageously adapted to receive a tube that is configured to transfergrafting and/or other fill materials from a syringe (or other supplysource) to the interior of the implant. Therefore, in such embodiments,the inside diameter (or other cross-sectional clearance dimension) ofthe port 50 is slightly larger than the outer diameter (or other outerdimension) of the fill catheter or other conduit.

In some embodiments, the port comprises a diameter of approximately 6 mmto 8 mm (e.g., about 6 mm, 6.5 mm, 7 mm, 7.5 mm, 8 mm, diameters betweenthe foregoing values, etc.). Alternatively, however, the diameter orother cross-sectional dimension of the port 50 can be smaller than about6 mm (e.g., approximately 4 mm, 4.5 mm, 5 mm, 5.5 mm, 5.9 mm, diametersbetween the foregoing values, etc.) or larger than about 8 mm (e.g.,approximately 8.1 mm, 8.5 mm, 9 mm, 9.5 mm, diameters between theforegoing values, larger than about 9.5 mm, etc.), as desired orrequired. In some embodiments, a target diameter or othercross-sectional dimension of the port 50 is generally maintained,irrespective of the size of the implant (e.g., 6 mm, 8 mm, 10 mm, 12 mmtall implants). This can help ensure that a surgeon or other cliniciancan insert a desired fill tube or other conduit within an interior of animplant (e.g., to delivery grafting and/or other fill materials during apost-fill procedure). Accordingly, as noted herein with reference to theembodiments illustrated in FIGS. 6B-6D, one or more implant wallsthrough which the port 50 passes (e.g., lateral side walls) may need tobe reinforced or otherwise strengthened to accommodate a desired portdiameter (e.g., 6 mm, 8 mm, etc.) in light of the implant's thickness.

By maintaining a relatively large port diameter or other dimension, alarger fill tube or conduit can be advantageously positioned throughsuch a port. Accordingly, the friction associated with passing graftingand/or other fill materials through the fill tube can be reduced. Thisallows for less strenuous delivery of grafting and/or other fillmaterials into the interior of an implant (e.g., during a post-fillprocedure). Accordingly, the surgeon or other clinician performing afill procedure can more easily deliver the necessary materials throughthe fill tube. Therefore, although it is somewhat counterintuitive toinclude a relatively large port or other openings along one or morewalls of the implant (e.g., because of the likelihood of grafting and/orother filler materials leaking out of the implant), such an oversizedport can provide one or more benefits and advantages during a fillprocedure.

According to some embodiments, the ratio of the port diameter (or otherport opening size) to the height of the implant wall through which theport is located (e.g., lateral wall) is between about 0.4 and about 0.9(e.g., approximately 0.4, 0.45, 0.5, 0.55, 0.6, 0.65, 0.7, 0.75, 0.8,0.85, 0.9, ratios between the foregoing values, etc.), depending on thesize of the implant. For example, in some embodiments, the port diameteris approximately 6 mm and the height of the corresponding implant wallis 8 mm, 10 mm, 12 mm or the like. Thus, the ratio can be approximately0.75, 0.6, 0.5 and/or the like. In some embodiments, the ratio of theport diameter (or other port opening size) to the height of the implantwall through which the port is located (e.g., lateral wall) is at leastabout 0.5, 0.55, 0.6, 0.65, 0.7, 0.75, 0.8, 0.85, 0.9, greater thanabout 0.9 and/or the like.

In some embodiments, the area of the port 50 is at least about 10%, 15%,20%, 25% or 30% of the overall area of the wall (e.g., lateral implantwall) through which the port is positioned. However, the port area canbe smaller than about 10% or greater than about 25% of the overall areaof the wall through which the port is positioned, as desired orrequired.

As discussed in greater below, the implants disclosed herein can beprovided in a variety of shapes, sizes and configurations in order tobetter accommodate the intervertebral spaces into which they will beinserted and secured. Thus, in some embodiments, the various types ofimplants that are supplied to a surgeon or other clinician comprise anidentical port 50 (e.g., having an identical diameter, shape, threadpattern, etc.), regardless of the actual size, shape and other detailsof the devices. Accordingly, a surgeon or other clinician can use asingle insertion tool and/or a single set of other instruments to engageand manipulate the various types of implants provided. Further, as notedabove, in addition to serving as a securement site and/or otherengagement means for a tool used during the delivery of the implantthrough a patient's anatomy, the port 50 can also be used as apassageway for a catheter, syringe, tube or other conduit. Such conduitscan be passed through the port 50 to selectively deliver graftingagents, other filler materials and/or any other device or substancewithin an interior chamber, cavity or other portion of the implant. Insome embodiments, the passage of catheters and/or other conduits throughthe port is performed after the implant has been securely positionedwithin a target intervertebral site and after one or more delivery toolshave been detached from the implant. In other embodiments, as disclosedherein, the graft delivery catheter or other conduit can be passedthrough the port 50 to reach an interior portion of the implant while animplant delivery tool is secured to the port. For example, such acatheter or conduit can be passed through an interior lumen or otherpassage of a cannulated implant delivery tool.

In order to maintain an identical threaded or other type of port 50, oneor more portions of smaller implants (e.g., implants that have a smallerheight, such as, for example, 6 mm, 8 mm or 10 mm devices) may bereinforced with additional material and/or other support along or nearan area surrounding the port 50. For example, as depicted in theembodiment illustrated in FIGS. 6B-6D, additional implant material 13(e.g., PEEK, other polymeric or other material, etc.) is included alongthe top and/or bottom surfaces of the implant 10 along or near the port50. This can advantageously permit the manufacture of implants ofvarious sizes that include a single type of port 50, while maintainingthe requisite structural and functional integrity of the implant. Forinstance, the use of additional material or other reinforcement 13 alongthe top and/or bottom surface of the implant 10 can provide therequisite resistance to the forces and moments to which the implant maybe subjected during delivery and/or use. As shown in FIGS. 6B-6D, inarrangements where additional reinforcing material 13 is provided alongthe top and/or bottom surfaces, such additional material can bepositioned within at least of the grooves that help define the teeth 40or other engagement features of the implant 10. Thus, the depth andgeneral configuration of the teeth 40 along such reinforced areas mayvary from adjacent areas of the implant.

Further, the implant 10 can include one or more additional features thatfacilitate engagement with a corresponding insertion tool. According tosome embodiments, as depicted, for example, in FIG. 3, the implantcomprises two recesses or slots 28 along one of the lateral ends 26(e.g., along the lateral end that includes the insertion tool receivingport 50). Such recesses or other features 28 can be sized, shaped,positioned, spaced, oriented and/or otherwise adapted to align and matewith corresponding wings, tabs or other portions of an insertion tool.The recesses, slots and/or other engagement features 28 can help asurgeon or other clinician to manipulate (e.g., rotate) the implantduring surgery or other procedure involving moving or repositioning theimplant. Further, such engagement features 28 can help ensure that thecorresponding implant insertion tool (and/or graft fill tool, asdiscussed in greater detail herein) is properly positioned relative tothe implant.

With continued reference to the embodiments depicted in, inter alia,FIGS. 1A, 1B and 2, the spinal implant 10 can include one or moreinternal chambers 70. In one embodiment, the implant comprises only asingle chamber. However, in alternative embodiments, the implantcomprises two or more chambers. As shown, such internal chambers 70 canextend across the entire implant depth (e.g., from the top surface 12 tothe bottom surface 16) and across a majority of the implant's length andwidth. For example, in some arrangements, the chamber 70 spansapproximately 60-70% of the implant length and width. However, in otherembodiments, the chamber 70 can extend less than about 60% of theimplant length and/or width (e.g., approximately 30%, 35%, 40%, 45%,50%, 55%, 60%, less than 30%, percentages between the aforementionedvalues, etc.), or more than about 70% of the implant length and/or width(e.g., approximately 70%, 75%, 80%, 85%, more than about 90%,percentages between the aforementioned values, etc.), as desired orrequired by a particular application or use.

In some embodiments, an implant comprises two or more chambers. Forexample, the implants illustrated in FIGS. 1A-5 can include one or moredividing walls (not shown) that extend across the chamber 70 generallybetween the anterior and posterior walls 92, 94. Such dividing walls orother separators, which may be integrally formed with adjacent portionsof the implant, can effectively create two or more sub-chambers orcavities in the implant. In implant arrangements having two or morechambers, sub-chambers, cavities and/or other openings, such chambers orsub-chambers can be of equal or different shape and/or size. Further,one or more openings can be included in the dividing wall or otherseparators to permit the chambers to be in fluid communication with oneanother. This may be particularly important when the filling the implantwith grafting and/or other materials (e.g., to help ensure that suchfill materials are delivered into all of the chambers).

As depicted in FIGS. 1A and 1B, a spinal implant 10 can include one ormore openings 60 that extend through its anterior wall 92, but noopenings along its posterior wall 94. The openings 60 can be in fluidcommunication with the implant's chamber(s) 70. Thus, as is discussed ingreater detail below, excess grafting and/or other fill materialsdelivered into the chamber(s) 70 (e.g., through a fill port 50 and/orother opening in the implant) can exit through the openings 60 towardthe anterior portion of the spine. By eliminating openings along theposterior wall, the passage of fill materials along the posterior sideof the implant can be generally reduced or prevented. Thus, a majority(or almost all) of excess grafting agent and/or filler materialdelivered within such an implant can be configured to exit the interiorof the implant through the anterior openings 60. For example, in somearrangements, more than approximately 70% (e.g., more than about 70%,75%, 80%, 85%, 90%, 95%, etc.) of excess fill materials delivered intoan implant exit through the openings 60. In some embodiments, this canadvantageously help prevent or reduce the likelihood of migration ofgrafting and/or other fill materials toward nerve roots, spinal cord andother sensitive regions of the spine.

With continued reference to the side view of the embodiment illustratedin FIG. 3A, an implant 10 can include a total of five openings 60 thatare generally equally sized and equally spaced apart from each otheralong the anterior wall. In the depicted configuration, the openings 60comprise an oval shape or a generally rectangular shape with roundedcorners. Alternatively, the openings 60 can include any other shape(e.g., circular, square, rectangular, other polygonal, irregular, etc.).Further, the quantity, spacing, relative size, orientation and/or othercharacteristics of the openings 60 can be different than illustrated anddiscussed herein. For example, depending on the implant's size, designbearing capacity and/or other properties, additional (e.g., six, seven,eight, nine, ten, more than ten, etc.) or fewer openings (e.g., four,three, two, one) can be provided.

In addition, as illustrated in, among other places, the top view of FIG.2, the implant 10 can comprise one or more internal prongs or otherprotruding members 74 that extend into the chamber 70. As with otherfeatures of the implant, such prongs 74 can be formed as a unitarystructure with adjacent portions of the implant. Alternatively, theinternal prongs 74 can be separate members that are subsequently securedto the implant using one or more connection devices or methods, such asfor example, screws, rivets, other fasteners, adhesives and/or the like.The prongs 74 can be positioned along various locations of the implant'sinterior surface. For example, in some embodiments, as illustrated inFIG. 6A and 6C, the prongs are positioned along various lateral portionsnear the top and/or bottom of the implant. However, the internal prongsor other engagement member can be situated along any other portion orarea of the chamber 70, either in addition to or in lieu of the topand/or bottom portions of the implant.

According to some embodiments, as depicted in FIG. 6D, the prongs 74 aredirected toward the interior chamber or cavity 70 of the implant 10. Theprongs 74 can be aligned generally perpendicularly relative to theinterior vertical wall that defines the chamber 70 and from which theprongs extend inwardly. Thus, one or more of the prongs can bepositioned along a line that is offset from the lengthwise or widthwisecenterline of the implant 10. For example, as shown in FIG. 6D, one ormore prongs 74 are offset by angle P relative to the widthwisecenterline W of the implant 10. In some embodiments, such an angle P isapproximately 20-25% (e.g., about 20%, 25%, 30%, etc.). Further, asillustrated in FIG. 6D, the prongs 74 can comprise a generally conical,wedge-like, truncated cone-like, triangular, pyramid-like and/or anyother shape (e.g., when viewed from the top). However, the shape, size,spacing, orientation and/or other characteristics of the prongs 74 canbe different than illustrated and discussed herein.

Regardless of their exact quantity, size, shape, spacing, orientationand/or other characteristics, such prongs or other features 74 can helpensure that grafting agents and/or other fill materials are properlyretained within the internal chamber(s) 70 of the implant 10. Forexample, in some embodiments, a solid graft, a porous foam structure, asponge and/or other solid or non-flowable member is positioned withinthe chamber 70 of the implant, either before or after implantation intoa patient. Thus, the prongs 74 can help engage such items and maintainthem within the implant. In some embodiments, the prongs 74 help securegrafting and/or other filler materials within a chamber 70 of theimplant only after such materials have become adequately hardened orsolidified.

As illustrated in FIGS. 1A-5, the thickness (e.g., vertical height) andwidth (e.g., anterior-posterior distance) of the implant 10 can begenerally consistent throughout its entire length. Alternatively, onelateral end of the implant can comprise a larger thickness than theopposite lateral end. Such arrangements can be advantageously used wheninserting an implant along to a lordotic portion of the spine. Forexample, the height difference between opposing ends in such lordoticimplants can differ by about 2 mm. In other embodiments, the heightdifference is less or greater than about 2 mm (e.g., approximately 0.5mm, 1 mm, 1.5 mm, 2.5 mm, 3 mm, 3.5 mm, 4 mm, greater than 4 mm,distances between the aforementioned values, etc.), as desired orrequired for a particular patient or fusion procedure.

According to some embodiments, the horizontal width of the implant'slateral walls 96, 98 can be configured to enhance the implant's abilityto withstand the bearing forces, moments and other loads to which itwill be subjected once properly implanted into a patient's spine. Forexample, as illustrated in the anterior-posterior view of FIG. 7A, thelateral walls 96, 98 of the implant 10 can be configured to align withportions B of the adjacent vertebrae V through which the highestconcentration of bearing forces are transferred to the implant 10. Ingeneral, such high bearing load areas or portions B are situated nearthe lateral or circumferential ends of the vertebrae V. Typically, asdepicted in FIG. 7A, the endplates of the vertebrae V move further awayfrom the adjacent intervertebral space near the center of the vertebralbody. Thus, most of the bearing load created by the adjacent vertebrae Vis expected to be concentrated toward the peripheral ends of the implant10.

Accordingly, in order to improve its load bearing capacity, the implant10 can include lateral walls 96, 98 that are generally reinforced andotherwise adapted to safely handle the bearing loads imposed upon theimplant following implantation. For example, the lateral walls 96, 98can be wider (e.g., horizontally) than the anterior and/or posteriorwalls 92, 94 of the implant. In some embodiments, the horizontal length(e.g., along the longer axis of the implant) of each of the lateralwalls 96, 98 is at least about two times greater than the horizontalwidth of the anterior or posterior wall. For instance, in someembodiments, the horizontal length of one or both of the lateral walls96, 98 is approximately at least two, three, four or more than fourtimes the horizontal width of the anterior wall or the posterior wall ofthe implant. In some embodiments, the horizontal length of one or bothof the lateral walls 96, 98 is approximately 10 to 20% (e.g., about 10%,12%, 14%, 16%, 18%, 20%, percentages between the foregoing values, etc.)of the overall horizontal length of the implant (e.g., along the longeraxis of the implant). Alternatively, however, the horizontal length ofthe one or both of the lateral walls 96, 98 can be greater than about20% or less than about 10% of the overall horizontal length of theimplant 10, as desired or required. Consequently, one or both of theimplant's lateral ends 22, 26 can be configured to better withstand thebearing forces and moments to which the implant it will be subjectedonce inserted and secured within a targeted intervertebral space of thepatient's spine.

According to some embodiments, a spinal implant is sized to generallyspan across the entire width of the adjacent vertebral members V. Thus,as discussed above, the lateral walls of the implant can be generallyaligned with the load bearing portions of the inferior and superiorvertebral members. In some embodiments, as discussed above withreference to FIG. 7A, the implant contacts the adjacent vertebralmembers primarily or only along the lateral ends of the implant. Thus,portions of the implant that are interior to the lateral ends of theimplant are configured to encounter less or no forces from the adjacentvertebral members.

According to some embodiments, the implant 10 comprises one or moreradio-opaque markers 80. Such markers 80 can facilitate a surgeon orother clinician to properly position the implant within the targetintervertebral space, especially when minimally invasive surgery isutilized. By way of example, as illustrated in FIGS. 1A, 1B and 2, theimplant 10 can include a total of three tantalum or other types ofradiopaque markers 80′, 80″. In the depicted arrangement, two markers80′ are located at or near the lateral ends 22, 26, while a third marker80″ is located at or near the horizontal center of the implant 10. Inone embodiment, the lateral or horizontal location of the middle marker80″ is exactly between the two lateral markers 80″. The quantity, type,location, orientation, spacing and/or other details of the markers canbe varied, in accordance with the specific requirements of anapplication or use.

As illustrated in the top view of FIG. 2, the posterior wall 94 of theimplant 10 can include a bump or other reinforced region 95 in order toaccommodate the center radio-opaque marker 80″. In addition to providingadditional material that can surround a marker, such bumps 95 or similarfeatures can advantageously improve the implant's strength and/or otherstructural characteristics.

The various configurations of the implants disclosed herein can includeone or more materials. For example, in some embodiments, the implantscomprise polyether etherketone (PEEK), other radiolucent materials,other thermoplastics, metals, alloys and/or any other materials havingthe desired structural (e.g., rigidity), mechanical, chemical andthermal resistance and/or other properties.

As discussed in greater detail herein, the size of the implant can beselected based, at least in part, on the patient's weight, height, age,the amount of intervertebral distraction that the implant should provideand/or any other factor or consideration. For example, in someembodiments, the implant is precisely selected based on the size of thepatient's intervertebral space into which the implant will be placed.For instance, the vertical height of the implant can vary betweenapproximately 8 and 14 mm (e.g., 8 mm, 10 mm, 12 mm, 14 mm, valuesbetween such ranges, etc.). As noted herein, the vertical height of theimplant can be consistent from the anterior end to the anterior end.Alternatively, the vertical height of the implant can vary in one ormore horizontal directions (e.g., anterior-posterior direction, lateraldirection, etc.).

In some embodiments, the implant includes a concave or other non-planar(e.g., domed, curvate, etc.) upper surface and/or lower surface. Such aconfiguration can help provide improved contact between the implant andthe endplate surfaces of the adjacent vertebrae. Further, the height ofthe implant can vary along the anterior-posterior direction. Forexample, in some embodiments, the vertical height of the anterior wallof the implant is approximately 2 mm higher than the vertical height ofthe posterior wall. Such a configuration can be advantageously used whenperforming fusion to a lordotic portion of the spine. Therefore, asnoted above, any of the fusion implants disclosed herein can havevertical dimensions that vary along their longitudinal direction. As aresult, a variety of different lordotic implants can be provided, suchas, for example, 8 mm by 10 mm (e.g., posterior height by anteriorheight), 10 mm by 12 mm, 12 mm by 14 mm implants and/or the like.

Moreover, the implant can be provided in a variety of horizontaldimensions in order to better accommodate the targeted intervertebralspace into which the implant will be inserted and secured. For instance,the length of the implant (e.g., from one lateral end to the other) canvary between 40 mm and 60 mm. In some embodiments, the implant isprovided in a variety of different lengths, such as, for example, 40 mm,45 mm, 50 mm, 55 mm, 60 mm, lengths between the foregoing values, etc.Alternatively, the length of an implant can be greater than 60 mm orsmaller than 40 mm, as desired or required. Likewise, the width (e.g.,the distance between the anterior and posterior ends) of the implant canvary, both from implant to implant and within a specific implant design.For example, in some embodiments, the width of the implant is betweenabout 19 mm and 21 mm. As discussed above with reference to FIG. 2, thewidth can vary along an implant's length. In some embodiments, such avariation in width results from rounded or curved anterior and/orposterior surfaces. Thus, in some embodiments, the implant comprises awidth of approximately 21 mm at its longitudinal center (e.g., at ornear the location of the middle marker 80″ is located in the arrangementdepicted in FIG. 2) and a width of approximately 19 mm at or near thelateral ends 22, 26. The implants can include any other shape, size ororientation, irrespectively of the specific examples provided herein.

Implantation into Targeted Intervertebral Space

The initial surgical steps in preparing a patient for a spinal fusionprocedure can include, among other things, making an incision along thepatient's skin and accessing a targeted region of the spine (e.g.,lumbar region) using one or more dilators, retractors and/or otherinstruments or tools. Depending on the state of the diseasedintervertebral disc or space, one or more preparatory steps may benecessary or recommended prior to delivery of the implant within thepatient's anatomy. For example, at least some of the native discmaterial can be removed in order to provide the necessary space for thesubsequent insertion of the implant. In some arrangements, a distractiontool is used to separate the vertebrae between which the implant will bepositioned.

Further, the surgeon or other clinician performing the procedure maychoose to size the target intervertebral space prior to implantation.For example, such a step can be performed in order to more accuratelyselect a properly sized implant. In addition, a surgeon may choose toprepare one or more native surfaces of the vertebrae that will beadjacent to the implant. For instance, one or more coarsening orabrading tools can be used to selectively roughen one or more portionsof the vertebral endplates adjacent to the implant. Under certaincircumstances, such a roughening step can promote healing and canaccelerate the fusion process following delivery of the implant withinthe spine.

FIG. 8 illustrates two different arrangements of a distraction andsizing tool 400A, 400B that can be used in advance of the delivery of animplant during a spinal fusion procedure. As shown, the distraction andsizing tool 400A, 400B can include a proximal handle 410A, 410B (whichis only partially depicted in FIG. 8) and a distal head 420A, 420B. Inthe depicted embodiments, the two tools 400A, 400B are substantiallysimilar to each other in overall design; however, their distal heads420A, 420B vary in size (e.g., vertical thickness, length, etc.). Aplurality of such distraction and sizing tools may be provided to asurgeon in order to allow him or her to determine what type of implantshould be inserted into targeted intervertebral space. Such tools 400A,400B can also be used to precisely distract or separate adjacentvertebrae in preparation for implantation.

In some embodiments, the sizing and distraction tool 400A, 400Bcomprises stainless steel, other metals or alloys and/or one or moreother rigid material that are adequate for insertion into a patient'sanatomy and configured to withstand the anticipated forces, momentsand/or other conditions (e.g., pH, temperature, etc.) to which they willbe subjected. With continued reference to FIG. 8, the sizing anddistraction tool 400A, 400B can include a baseline marker 430A, 430B ator near the distal end of the head 420A, 420B. In some arrangements, thesurgeon can insert the tool's head 420A, 420B within the targetintervertebral space and advance the tool (e.g., under the guidance ofx-ray, ultrasound, fluoroscopy and/or other imaging technology) untilthe baseline marker 430A, 430B exactly or approximately aligns with theperipheral distal edge of the adjacent vertebral bodies. Once the distalend of the head has been aligned, the surgeon can use the proximalmarkings 440A, 442A, 444A, 446A, 448A to determine the appropriatelength of the intervertebral space. For example, the length can bedetermined based on the proximal marking that is closest to theperipheral proximal edge of the adjacent vertebral bodies. Thus, themarkings 440A, 442A, 444A, 446A, 448A can be visualized using one ormore imaging technologies to determine the proper implant size for thetargeted intervertebral space.

Likewise, the surgeon can attempt to position tools 400A, 400B ofvarying head thickness into a targeted intervertebral space in order todetermine a desired implant height. Accordingly, the sizing anddistraction tool 400A, 400B can be used to select a well-suited implantfor insertion into the patient's spine. In some embodiments, such a tool400A, 400B can be used to create a desired level of vertical distractionwithin the targeted intervertebral space, especially if the adjacentvertebral bodies are undesirably close to one another (e.g., due tosevere disc degeneration and/or disease).

FIG. 9 schematically illustrates one embodiment of a shaver 500configured to selectively rasp, abrade and/or otherwise compromise orremove tissue. In some arrangements, the shaver 500 is inserted into anintervertebral space to remove disc tissue and/or prepare the vertebralendplate surfaces for the subsequent delivery of a spinal implant. Asshown, the shaver 500 can comprise an abrading assembly 520 positionedalong a distal end of a longitudinal shaft 510. The abrading assembly520 can include a center or main portion 534 located between a pair oftapered outer portions 530A, 530B. In some embodiments, the centerportion 534 comprises one or more abrading members 540 that are adaptedto contact and at least partially remove, abrade or otherwise affecttissue. Thus, as the shaft 510 is rotated about a longitudinal axis 514,the abrading member 540 can help remove native disc tissue and/or attackthe endplate wall in preparation for the subsequent implantation of thefusion device. In some embodiments, as illustrated in FIG. 9, the shaver500 comprises tapered or lower profile outer portions 530A, 530B so asto reduce or prevent damage to the peripheral bearing areas B of thevertebral members V (see FIG. 7A). By avoiding or reducing thelikelihood of damage to these native load bearing portions B of adjacentvertebrae, the structural integrity of the patient's spine, and thus thefusion procedure, can be maintained.

A different embodiment of a shaver instrument 550 is schematicallyillustrated in FIGS. 10A and 10B. As shown, the shaver 550 comprises amain portion 560 that is shaped, sized and otherwise configured fordelivery into a targeted intervertebral space. The upper and lowersurfaces of the main portion may or may not include teeth or otherengaging features or members. In some arrangements, the main portion 560includes a central chamber or other opening 570 that generally extendsfrom the top to the bottom surface of the main portion 560. As depictedin FIG. 10A, an access port or opening 564 can provide access from alateral side of the main portion 560 to the interior of the centralchamber 570. An abrading assembly 590 can be positioned along the distalend of an elongated member 580. The elongated member 580 can be sized,shaped and otherwise adapted for passage through the access port 564 ofthe main body. Likewise, the abrading assembly 590 can be configured forplacement within the chamber 570 of the main portion 560. According tosome embodiments, the abrading assembly 590 is configured for selectivemovement within the central chamber 570 as the elongated member 580 isrotated about a longitudinal axis 582.

With continued reference to FIG. 10B, the abrading assembly 590 cancomprise a generally horizontal configuration. As shown, the abradingassembly 590 can include one or more lateral wing portions 592positioned on either side of the elongated member 580. In someembodiments, the outer surface 594 of each wing portion 592 can includeone or more abrasive members or features 596 that are adapted to contactand at least partially remove or damage tissue. In some arrangements,the abrading assembly 590 is fully retained within the central chamber570 when in the illustrated low profile or stowed orientation. Thus, theshaver 550 can be delivered to the patient's spine without interferenceby the abrading assembly 590. Once properly positioned within the targetintervertebral space, the surgeon or other clinician can selectivelyrotate the elongated member 580 to move the distal wing portions 592toward the adjacent tissue (e.g., native disc tissue, endplate surfaces,etc.). Thus, continued and repetitive rotation of the abrading assembly590 can cause a desired amount of abrasion to the adjacent vertebralmembers in preparation for delivering the implant device to theintervertebral space. In some embodiments, the central chamber 570 ofthe shaver 550 generally aligns with a central portion of the adjacentvertebrae between the peripheral bearing areas B (FIG. 7A). Thus, damageto the load bearing areas B of the vertebrae can be reduced or avoided,as the abrading assembly 590 will be generally confined to a limitedcentral portion of the adjacent vertebral members. Consequently, asnoted above, the structural integrity of the adjacent bearing areas ofthe vertebral members can be advantageously maintained.

FIG. 11 illustrates a perspective view of a spinal implant 10, identicalor similar to those disclosed herein, secured to a distal end of aninsertion tool assembly 300 according to one embodiment. An explodedview of the insertion tool assembly 300 of FIG. 11 is provided in FIG.12A. As shown in FIGS. 11 and 12A, the insertion tool 300 can include anouter elongated member 310 having a distal end 312 that is adapted toreleasably engage a spinal implant 10. In some embodiments, the distalend 312 of the outer elongated member 310 comprises a pair of wings ortabs 314 that are sized, shaped and otherwise configured to engagecorresponding recesses or slots 28 (FIG. 1A) of an implant 10.

With continued reference to FIGS. 11 and 12A, the outer elongated member310 can include an inner passage 316 that extends from the proximal end320 to the distal end 312 of the insertion tool assembly 300. Thus, insome embodiments, the outer elongated member 310 is cannulated. Theproximal portion 320 of the assembly 300 can include a handle 322 and aflared end 328. According to some embodiments, the outer elongatedmember 310 includes one or more windows 324 at or near the handle. Asdiscussed in greater detail below, such a window can permit access to athumbwheel or other movable control member that daylights or is exposedthrough the window 324.

As depicted in FIGS. 11 and 12A, the outer elongated member 310 can beconfigured to slidably receive a threaded rod 340 within its innerpassage or opening 316. In some embodiments, the threaded rod 340comprises a main elongated portion 344 having a threaded distal end 346.The threaded distal end 346 can be shaped, sized and otherwise adaptedto engage a corresponding port 50 of a spinal implant (FIG. 1A). Apartial cross-sectional view of such threaded engagement between thedistal end 346 of the rod 340 and the port 50 of the implant 10 isillustrated in FIG. 12B. When the main elongated portion 344 is properlyinserted within the cannulated opening of the outer member 310, thethreaded distal end 346 can extend through the distal end of the opening316, generally between the wings or tabs 314 of the outer member 310.

As depicted herein, the proximal end of the threaded rod 340 cancomprise a generally cylindrical thumbwheel 348 that includes a largerdiameter than the adjacent main elongated portion 344. According to someembodiments, at least a portion of the thumbwheel 348 is accessiblethrough the window(s) 324 of the outer elongated member 310 when theinsertion tool assembly 300 is properly assembled for use. Thus, asurgeon or other clinician can selectively rotate the thumbwheel 348while grasping the insertion tool assembly 300 to either engage orrelease the implant from the assembly's distal end. The thumbwheel 348can include a plurality of longitudinal grooves 349 and/or otherfeatures that can facilitate rotation of the threaded rod relative tothe outer elongated member 310.

With continued reference to FIGS. 11 and 12A, a hammer or strike pad 360can be secured to the proximal end of the outer elongated member 310once the threaded rod 340 has been properly positioned therein.According to some embodiments, the hammer pad 360 includes distalthreads 366 or other engagement features that are configured to engagecorresponding threads or features of the outer elongated member 310.Thus, the hammer pad 360 can be releasably attached to the outerelongated member 310.

Once the targeted intervertebral space has been prepared (e.g., inaccordance with a desired or required protocol), a spinal implant 10 canbe secured to the distal end 312 of the insertion tool assembly 300. Forexample, as discussed above, the threaded distal end 346 of the rod 344can threadably secure to the access port or opening 50 along a lateralend of the implant 10. Further, the tabs or wings 314 of the outerelongated member can engage corresponding recesses 28 of the implant 10.The insertion tool assembly 300 and the implant 10 can include one ormore other types of corresponding mating or engaging features ormembers, either in lieu of or in addition to those disclosed herein.

Once the implant has been properly secured to the distal end of theinsertion tool assembly 300, the surgeon or other clinician can drivethe implant 10 into the targeted intervertebral space. In someembodiments, the insertion tool assembly 300 can be advanced into theanatomy (e.g., against any resistive forces) by impacting the proximalend of assembly 300 with a slap hammer assembly 380, a mallet or anyother tool or instrument. The implantation procedure can be performedunder real-time visualization in order to ensure that the implant isproperly advanced and positioned.

The various components of the insertion tool assembly 300 disclosedherein, including the outer elongated member 310, the threaded rod 340and the hammer pad 360, can comprise one or more rigid materials, suchas, for example, hardened stainless steel, other types or grades ofsteel, titanium, other metals or alloys, composites, other natural orsynthetic materials and/or the like. Such components can be reusable(e.g., sterilizable) or disposable, as desired or required.

Filling of the Implant

Once the implant has been properly positioned within the targetedintervertebral space, the internal chamber(s) of the implant can be atleast partially filled with one or more grafting materials, other fillmaterials and/or the like. For example, the various materials that canbe delivered to the internal chamber(s) of an implant include, but arenot limited to: bone forming cells, demineralized bone matrix (DBM),bone morphogenetic protein (BMP), collagen matrix, bone cement, otherflowable grafting agents or materials, flaky or other non-flowablegrafting agents or materials, other biological or non-biologicalmaterials or substances and/or any other grafting or filler material.

As noted herein, in some embodiments, the implant is at least partiallyprefilled with one or more grafting agents, other fillers and/or anyother material or item prior to implantation. For example, in somearrangements, a sponge, foam, other porous structure or member or otherabsorbent member is positioned within the implant's chamber prior toadvancing the implant within the anatomy. Such an absorbent member caninitially include one or more graft materials and/or can be configuredto absorb or otherwise retain graft materials that are delivered intothe chamber after the implant has been positioned with the targetedintervertebral space. In other arrangements, one or more graft materialsand/or other fill materials can be provided in solid or partially-solidform within the implant's internal chamber(s) prior to implantation.Regardless of what items or materials are positioned within the implantprior to its delivery within a patient's spine, one or more internalprongs 74 (FIG. 2), other protruding members and/or other retainingfeatures can be used to securely maintain such items or materials withinthe implant. As discussed herein, such prongs or other protrudingmembers are configured to engage and retain materials contained withinan internal chamber or cavity of the implant after such materials haveat least partially solidified or cured.

According to some embodiments, once the spinal implant has been properlyimplanted, the insertion tool assembly 300 (FIGS. 11 and 12A) isdecoupled from the implant and the assembly 300 is removed. In someembodiments, a fill tool assembly is subsequently inserted into anatomyin order to engage the implant and selectively deliver graft and/orother types of materials into the implant's internal chamber. Such afill tool assembly can include a catheter, tube, syringe and/or otherconduit that is sized, shaped and otherwise adapted to be positionedthrough one or more ports of the implant. As discussed in greater detailherein, such a port 50 can be identical to the port that is also used tosecure the implant to the distal end of a delivery tool during deliveryof the implant within the patient's anatomy. One embodiment of a kit 600that comprises, among other things, a fill tool assembly 610 isillustrated in FIG. 13.

As illustrated in FIG. 13, a fill kit 600 can include one or more of thefollowing items: a fill tool assembly 610, a coupler 640, a syringeassembly S, a mixing tray T, a container of graft or other fill materialG and/or the like. As noted above, the graft and/or other types of fillmaterials can be selected by the surgeon or other clinician according toa desired or required protocol or procedure. The mixing tray T can beused to combine, mix, dilute or otherwise process the various graftand/or other fill materials that will be selectively transferred withinor near the implant. The various components included in the kit 600 canbe disposable or reusable, as desired or required. Thus, such componentscan include one or more rigid, semi-rigid and/or flexible materials,including metals or alloys (e.g., stainless steel), polymeric orthermoplastic materials, rubber or other elastomeric materials,composites, other natural or synthetic materials and/or the like.

According to some embodiments, as depicted in FIG. 13, the fill toolassembly 610 includes an elongated cannulated shaft 614 that terminatesin a distal end 620. The distal end 620 can include a discharge opening616 that is in fluid communication with the internal passage of theshaft 614. Further, the distal end 620 of the fill tool assembly 610 cancomprise one or more tabs or wings 622 that are sized, shaped andotherwise configured to engage corresponding recesses 28 or otherfeatures of the implant 10 (FIG. 1B). Although such tabs 622, wings orother alignment features are not necessary, they can provide assurancethat the fill tool assembly has been properly positioned relative to theimplant in anticipation of the subsequent filling steps. The proximalend 630 of the fill tool assembly 610 can include a handle. In thedepicted embodiment, the proximal end 630 comprises a number of ringshaped portions. One embodiment of a fill tool assembly 610 aligned andengaged with an implant 10 that has been properly secured within atargeted intervertebral space is illustrated in FIG. 14.

With continued reference to FIG. 13, graft or other fill materials canbe loaded into a syringe 650 of a syringe assembly S. As shown, thesyringe 650 can include a barrel portion 652 into which the graft and/orother fill materials are placed. Further, the syringe 640 can include aplunger 658 that can be selectively advanced within the barrel 652 inorder to help urge the graft and/or other fill materials out of thedistal exit opening 654 of the syringe 650. In addition, the syringe caninclude a pair of grasping members 656 to facilitate handling andmanipulation during use. Further, one or more mechanical tools can beused to assist the surgeon or other clinician in slidably displacing theplunger or similar movable member within the barrel. The use of suchsyringe/plunger configurations can be particularly helpful whentransferring graft and/or other fill materials that are relativelythick, dense, concentrated, viscous or otherwise difficult to move.

As shown in the exploded view of FIG. 13, a discharge coupling 660 canbe used to attach the distal end of the syringe 650 to a length offlexible catheter, tubing or other conduit 670. In some embodiments, thetubing 670 is cable-lined and/or otherwise reinforced to reduce thelikelihood of kinking during use. Such cable-lined tubing can also beused to confirm its location within the anatomy during use, as the cablelining can be visualized using one or more visualization technologies.The coupling 600 can be permanently or removably secured to the syringe650 and/or the tubing 670 using one or more types of connection methodsor devices, such as, for example, luer connections, threadedconnections, friction fit or press fit connections, other types offasteners, adhesives and/or the like. A perspective view of oneembodiment of a fully-assembled syringe assembly S is illustrated inFIG. 15.

According to some embodiments, the flexible tubing or other conduit 670and/or other components of the syringe assembly S retain the samecharacteristics, irrespective of the type of spinal implant that will befilled. For example, the length of the tubing 670 and coupling can bemaintained consistent or substantially consistent in all kits 600. Thus,in some embodiments, a coupler 640 can be used to ensure that a volumeof graft and/or fill material is adequately, accurately and consistentlydelivered to the implant.

As illustrated in FIG. 13, the coupler 640 can be configured to receiveand engage the proximal end of the fill tool assembly 610 through itsdistal opening 642. Likewise, the coupler 640 can receive and engage adistal end of the syringe assembly S through its proximal opening 644.In some arrangements, the coupler 640 is selected based on the sizeand/or type of spinal implant that will be filled. Such a configurationcan help ensure that the distal end of the syringe assembly's tubing,catheter or other conduit 670 is properly positioned within theimplant's internal chamber at the initiation of the graft filling stage.For example, according to some embodiments, the coupler 640 is generallylonger for the filling of smaller (e.g., shorter) implants, andgenerally shorter for the filling of larger (e.g., longer) implants. Akit 600 can be provided with a number of differently sized couplers 640from which a clinician can choose (e.g., depending on the type ofimplant that will be at least partially filled). Further, the couplers640 can include a size identifier 646, such as, for example, the lengthof the implant to be filled.

FIGS. 16A-16C illustrate three time-sequential steps performed inpreparation for a post filling procedure, in which grafting and/or otherfill materials are delivered within an interior portion of a spinalimplant following implantation. In FIG. 16A, the fill tool assembly 610has been properly secured to the implant 10. For example, as notedabove, the tabs or wings along the distal end of the fill tool assembly610 can be aligned with and mated with corresponding recesses of theimplant. As shown, a properly selected coupler 640 can be positionedalong the proximal end of the fill tube assembly 610. In somearrangements, one or more engagement members or features are positionedwithin the distal end of the coupler 640 to ensure that the proximal endof the fill tube assembly 610 has been properly positioned therein.

Next, as illustrated in the side view of FIG. 16B, the syringe assemblyS is inserted within and advanced (e.g., in a direction generallyrepresented by arrow A) relative to the coupler 640 and the fill toolassembly 610. FIG. 16C shows the syringe assembly S advanced to its fulldistal position relative to the coupler 640. Accordingly, in someembodiments, if the appropriately sized coupler 640 was used, the distalend of the tubing should be properly positioned within the chamber ofthe implant 10. Accordingly, the coupler assists the surgeon toaccurately position the distal end of the conduit or other tubing withinan internal chamber, along a specific longitudinal location of theimplant. Thus, the surgeon can reliably and confidently begin injectingthe graft and/or other filler materials loaded into the syringe 650 intoa chamber or other interior portion of the implant 10.

According to some post fill arrangements, the surgeon can select adesired volume of graft and/or other filler materials that will betransferred to the chamber of the implant 10 according to his or her ownrequirements and protocols. In some embodiments, the maximum internalvolume of each type of implant is provided to the clinician incorresponding printed literature, on the implant itself, usinggraduation marks on the syringe and/or the like.

According to some embodiments, the surgeon or clinician continues toinject the graft and/or other filler material into the interior chamberof the implant by manipulating the syringe plunger and/or by actuatingsome other mechanical device (e.g., hand-operated ratchet, othermotorized device, etc.) that facilitates much manipulation of theplunger. The surgeon can choose to slowly, either incrementally orcontinuously, retract the syringe assembly S, and thus the distal end ofthe tubing, catheter or other conduit, while the graft and/or other fillmaterial is delivered to the implant 10. This can facilitate and promotemore even distribution of the graft and/or fill material within theinternal chamber. In some embodiments, the syringe barrel, the couplerand/or any other component or features of the syringe assembly Scomprise graduation marks or other indicia to assist the clinician indetermining how much and/or at what rate to retract the tubing duringuse.

In some arrangements, the amount of graft and/or other fill materialsdelivered to the implant generally exceeds the internal capacity of thechamber. Thus, at some point, excess graft and/or other fill material Gcan be expected to begin discharging out of one or more implant openings60 (e.g., openings located along anterior wall of the implant). This isillustrated in the embodiment depicted in FIGS. 17A and 17B. As notedabove, in some embodiments, the posterior wall of the implant does notcomprise any openings. Further, excess graft and/or other fill materialcan also be directed at the upper and/or lower interfaces of the implantand the adjacent vertebral endplate surfaces. According to somearrangements, as discussed herein, the orientation of the teeth or otherengagement members along the upper and/or lower surfaces of the implantcan help prevent, reduce the likelihood of and/or slow down the flow ofexcess graft and/or other fill material across the implant-endplateinterfaces.

According to some embodiments, excess graft and/or other fill material Gcan generally fill any gap that exists between the vertebral endplatesand the adjacent surfaces of the implant. This can result in improvedspinal fusion. Further, spinal fusion can benefit from the excess graftand/or other fill material that exits through the openings 60 along theanterior wall of the implant 10. As illustrated in the embodiment ofFIGS. 17A and 17B, such material G can fill any gaps that exist betweenthe implant and the remaining disc material and/or other tissue alongthe anterior end of the spine. For example, excess graft and/or otherfill material G can at least partially cover the anterior face of theimplant, can span the vertical gap between adjacent vertebral Vendplates along the anterior side of the implant and/or can migrate toother portions along the anterior end and/or the lateral ends of theimplant to help improve fusion. As noted above, similar openings alongthe posterior wall of the implant can be eliminated in order to preventor reduce the likelihood of excess graft and/or other fill materialsfrom migrating to nerve roots, the spinal cord and/or other sensitiveportions of the patient's spine.

According to some embodiments, as illustrated in the partial crosssectional view of FIG. 18, the threaded rod 340′ of the insertion toolassembly 300′ can be cannulated. Thus, the insertion tool 300′ can beused to both deliver the implant to its proper intervertebral positionand to subsequently fill the interior chamber(s) of the implant 10 withone or more graft and/or other fill materials. For example, in thedepicted arrangement, the internal passage 341′ of the cannulatedthreaded rod 340′ can be sized, shaped and otherwise configured toreceive a flexible tube, catheter or other conduit of a syringeassembly. Accordingly, the need to disengage the implant 10 from thedistal end of the insertion tool assembly 300′ and engage a separatefill tool assembly (as discussed herein with reference to severalembodiments) can be eliminated. Instead, the insertion tool assembly300′ can remain engaged to the implant 10 while a fill tube or otherconduit is inserted within the internal passage 341′ of the cannulatedrod 340′. Once the desired or required amount of grafting agents and/orother fill materials has been transferred to the implant, the fillconduit and the insertion tool assembly can be removed from the patientanatomy. In some embodiments, the hammer or strike plate 360 (FIG. 12A)can include a corresponding opening through which the tubing can berouted to reach the passage 341′ of the cannulated rod 340′.Accordingly, the cannulated rod 340′, as with any other components ofthe insertion tool and/or fill assemblies, can be disposable.

As discussed in relations to several embodiments disclosed herein, aspinal fusion procedure can comprise an initial implant delivery stepfollowed by a subsequent filling step. Thus, in some embodiments, theimplant is delivered within the patient's anatomy with its internalchambers or cavities either empty or only partially filled with graftingagents, other filler materials and/or other components. For example, asdiscussed above, an implant can comprise a porous foam, a sponge and/orone or more other absorbent devices or materials prior to its deliverywithin a target intervertebral space. In such an embodiment, no othermaterials (e.g., grafting agents, other filler materials, etc.) arepresent within the implant prior to or during delivery of the implant.In other arrangements, an interior chamber or other cavity of theimplant is only partially filled with graft and/or other fillermaterials prior to or during delivery to the target interbody space.

In accordance with the various embodiments and examples disclosedherein, one or more biological and/or non-biological grafting and/orother fill materials can be injected or otherwise delivered within ornear the implant following implantation. Such a procedure can helpensure that grafting and/or other filler materials are not lost duringthe delivery of the implant within the patient (e.g., due to hammeringor other impact forces imparted on the implant during such deliveryprotocols). Further, by delivering excess fill materials within or nearthe implant, as discussed herein, more enhanced fusion of the implant toadjacent spinal surfaces (e.g., endplate surfaces) can be advantageouslyprovided.

Yet another embodiment of a spinal implant 1100 is illustrated in FIGS.19-21. As shown, the implant 1100 can include top and bottom surfaces1112, 1114 having one or more teeth 1122 and/or other featuresconfigured to engage corresponding portions of the patient's vertebralmembers (e.g., adjacent endplate surfaces). In addition, as discussedherein with respect to other embodiments, the depicted implant 1100comprises one or more anterior holes or openings 1134 a, 1134 b throughwhich excess grafting and/or other filler materials can exit theinterior chambers or cavities 1116 a, 1116 b of the implant 1100.Further, in some embodiments, the posterior wall of the implant does notcomprise any openings, thereby preventing or reducing the likelihoodthat excess grafting and/or other fill materials will move in thatdirection.

With continued reference to FIGS. 19 and 20, as with any embodimentsdisclosed herein, the implant 1100 can comprise one or more interiorwalls 1132 or baffles that divide an interior chamber or cavity into twoor more areas. In some embodiments, such separate interior chambers,cavities or areas 1116 a, 1116 b can be in fluid communication with oneanother via one or more openings 1134 or other orifices within theinterior wall or baffle 1132. However, in some embodiments, an implantdoes not comprise any interior walls or baffles. Thus, an implant caninclude only a single relatively large interior chamber or cavity, whilemaintaining a desired load bearing capacity and other structural designcriteria.

As with other embodiments disclosed herein, the implant 1100 can beadvantageously sized, shaped and otherwise configured to span or extendacross the entire or substantially the entire width of the inferior andsuperior vertebral members between which it is to be placed and secured.Further, the lateral ends 1118, 1120 of the implant 1100 can compriserelatively large walls that generally coincide with load bearingportions of the adjacent vertebral members (see, for example, FIGS. 7Aand 21).

As noted herein with regards to other implant arrangements, the depictedimplant 1100 can comprise one or more ports 1136 along one or more ofits surfaces. For example, as illustrated in FIGS. 19-21, a single port1136 can be provided along one of the lateral side walls of the implant1100. As discussed in greater detail herein, such a port 1136 can beconfigured to receive an implant delivery tool (e.g., to assist asurgeon in moving the implant through the patient's anatomy to a targetintervertebral space) and/or to pass one or more fill tubes or conduitsfor post-filling, at least partially, an interior chamber or cavity ofthe implant with grafting agents and/or other fill materials. In any ofthe implant embodiments disclosed herein, or equivalents thereof, such aport that can serve a dual purpose related to implant positioning andgraft delivery can be located along any side wall (e.g., lateral,anterior, posterior) of the implant.

In addition, as illustrated in FIG. 20, a cap or other sealing member1138 can be secured to the port 1136. Such a cap 1138 can help ensurethat grafting and/or filler materials delivered or otherwise positionedwithin the interior of the implant do not escape through the port 1136.In other embodiments, the port can comprise one or more valves or otherflow blocking members to help reduce the inadvertent escape of materialsfrom the interior of the implant.

With reference to the side cross-sectional view of FIG. 21, the implantport can be sized, shaped and otherwise configured to receive a filltube or other conduit 1200. Such a fill tube 1200 can be passed throughthe port and into one or more interior chambers or other cavities of theimplant 1100. As shown, a distal end 1220 of the fill tube 1200 can beangled so that the outlet 1212 is oriented generally perpendicular tothe axis A of the port and the fill tube 1200. In other embodiments, theface of the outlet 1212 can be oriented along a different angle (e.g.,between 0 and 90 degrees relative the longitudinal axis A), as desiredor required. In some embodiments, a plunger assembly 1206 can bepositioned within the fill tube or can be operatively coupled to it.Accordingly, such a plunger assembly 1206 can be selectively actuated inorder to provide the necessary driving force to move grafting material Gthrough the tube 1200 and into an interior area of the implant.

According to some embodiments, as illustrated in FIG. 21, the top and/orbottom surfaces of a spinal implant can be generally curved or rounded.In such arrangements, the curvature of the top and/or bottom surface canbe configured to match or generally align with the shape of the adjacentendplates E or other native tissue of the patient. However, as discussedabove with reference to the implant embodiment illustrated in FIGS. 1Aand 1B, the top and/or bottom surfaces can be generally planar.

To assist in the description of the disclosed embodiments, words such asupward, upper, bottom, downward, lower, rear, front, vertical,horizontal, upstream, downstream have been used above to describedifferent embodiments and/or the accompanying figures. It will beappreciated, however, that the different embodiments, whetherillustrated or not, can be located and oriented in a variety of desiredpositions.

Although the subject matter provided in this application has beendisclosed in the context of certain specific embodiments and examples,it will be understood by those skilled in the art that the inventionsdisclosed in this application extend beyond the specifically disclosedembodiments to other alternative embodiments and/or uses of the subjectmatter disclosed herein and obvious modifications and equivalentsthereof. In addition, while a number of variations of the inventionshave been shown and described in detail, other modifications, which arewithin the scope of these inventions, will be readily apparent to thoseof skill in the art based upon this disclosure. It is also contemplatedthat various combinations or subcombinations of the specific featuresand aspects of the embodiments may be made and still fall within thescope of the inventions disclosed herein. Accordingly, it should beunderstood that various features and aspects of the disclosedembodiments can be combine with or substituted for one another in orderto form varying modes of the disclosed inventions. Thus, it is intendedthat the scope of the subject matter provided in the present applicationshould not be limited by the particular disclosed embodiments describedabove, but should be determined only by a fair reading of the claimsthat follow.

1. (canceled)
 2. A method of promoting spinal fusion in a spine of asubject, comprising: advancing an implant between a first vertebra and asecond vertebra of the subject, the implant comprising an internalchamber; and directing graft material into the internal chamber of theimplant through a passageway of the implant, after positioning theimplant between the first and second vertebrae, such that graft materialat least partially contacts endplate surfaces of both the first andsecond vertebrae; wherein the internal chamber of the implant, afterimplantation, extends from or near the first vertebra to or near thesecond vertebra; and wherein graft material directed into the at leastone internal chamber is substantially retained between the first andsecond vertebrae.
 3. The method of claim 2, wherein the implant isadvanced through the anatomy of a patient and positioned between thefirst and second vertebrae using a lateral approach.
 4. The method ofclaim 2, wherein the implant is advanced through the anatomy of apatient and positioned between the first and second vertebrae using atransforaminal approach.
 5. The method of claim 2, wherein the implantis advanced through the anatomy of a patient and positioned between thefirst and second vertebrae using an anterior or a posterior approach. 6.The method of claim 2, wherein the implant is configured to create avertical distraction between the first vertebra and the second vertebra.7. The method of claim 2, wherein directing the graft material into theinternal chamber comprises using a graft material delivery system, thegraft material delivery system comprising a conduit, wherein a volume ofgraft material is configured to be delivered to the internal chamber ofthe implant via the conduit.
 8. The method of claim 7, wherein directingthe graft material into the internal chamber comprises placing theconduit in fluid communication with the passageway of the implant toprovide access to the internal chamber of the implant.
 9. The method ofclaim 7, wherein the graft delivery system further comprises a plungerassembly configured to be positioned and moved within the conduit, themethod further comprising actuating the plunger assembly to provide thenecessary driving force to move a volume of graft material through theconduit and into the internal chamber of the implant.
 10. The method ofclaim 2, wherein graft material is directed into the internal chamber ofthe implant so that at least a volume of the graft material deliveredinto the internal chamber exists through an interface between anendplate surface of the first or second vertebra and an upper or a lowersurface of the implant.
 11. A method of promoting spinal fusion in aspine of a subject, comprising: advancing an implant between a firstvertebra and a second vertebra of the subject, the implant comprising atleast one internal chamber, wherein the at least one internal chamber ofthe implant, after implantation, extends from or near an endplate of thefirst vertebra to or near an endplate of the second vertebra; anddirecting graft material into the at least one internal chamber of theimplant through a passageway of the implant, after positioning theimplant between the first and second vertebrae, wherein the passagewayof the implant provides access from the at least one internal chamber toan outside of the implant; wherein a volume of graft material isdirected into the at least one internal chamber of the implant so thatgraft material at least partially contacts the endplates of both thefirst and the second vertebrae.
 12. The method of claim 1, wherein theimplant is advanced through the anatomy of a patient and positionedbetween the first and second vertebrae using a lateral, atransforaminal, a posterior or an anterior approach.
 13. The method ofclaim 11, wherein directing the graft material into the at least oneinternal chamber comprises using a graft material delivery system, thegraft material delivery system comprising a conduit, wherein a volume ofgraft material is configured to be delivered to the at least oneinternal chamber of the implant via the conduit.
 14. The method of claim13, wherein the graft delivery system further comprises a plungerassembly configured to be positioned and moved within the conduit, themethod further comprising actuating the plunger assembly to provide thenecessary driving force to move a volume of graft material through theconduit and into the at least one internal chamber of the implant. 15.The method of claim 11, wherein the implant is configured to create avertical distraction between the first vertebra and the second vertebra.16. The method of claim 11, wherein graft material is directed into theat least one internal chamber of the implant so that at least a volumeof the graft material delivered into the at least one internal chamberexists through an interface between an endplate surface of the first orsecond vertebra and an upper or a lower surface of the implant.
 17. Amethod of promoting spinal fusion in a spine of a subject, comprising:advancing an implant between a first vertebra and a second vertebra ofthe subject, the implant comprising at least one internal chamber,wherein the at least one internal chamber of the implant, afterimplantation, extends from the first vertebra to the second vertebra;and directing graft material into the at least one internal chamber ofthe implant, after positioning the implant between the first and thesecond vertebrae; wherein at least a portion of graft material directedinto the at least one internal chamber extends from or near an endplateof the first vertebra to or near an endplate of the second vertebra. 18.The method of claim 17, wherein the implant is advanced through theanatomy of a patient and positioned between the first and secondvertebrae using a lateral, a transforaminal, a posterior or an anteriorapproach.
 19. The method of claim 17, wherein the implant is configuredto create a vertical distraction between the first vertebra and thesecond vertebra.
 20. The method of claim 17, wherein directing the graftmaterial into the at least one internal chamber comprises using a graftmaterial delivery system, the graft material delivery system comprisinga conduit, wherein a volume of graft material is configured to bedelivered to the at least one internal chamber of the implant via theconduit.
 21. The method of claim 17, wherein graft material is directedinto the at least one internal chamber of the implant so that at least avolume of the graft material delivered into the at least one internalchamber exists through an interface between an endplate surface of thefirst or second vertebra and an upper or a lower surface of the implant.